Snr QC Associate
Marin Metro Area, CA
This position will assist with management of QC contract testing and production related activities. Key responsibilities may include:
- Provide support in organizing QC contract testing and cell bank production activities.
- Serve as point of contact between contract laboratories and internal groups.
- Assist with management of in-country testing and provide updates to team and management.
- Establish effective communication and collaborative relationships with other functional groups and key stakeholders.
- Maintain tracking spreadsheets/databases for contract testing lab activities and information.
- Provide updates on testing status to QC labs and management.
- Serve as point of contact for contract laboratories and internal groups.
- Attend meetings as QC Contract Laboratory Management representative and provide updates and input as necessary.
- Generate and/or revise Quality Technical Agreements with contract testing labs and contract cell bank manufacturers.
- Generate legal contract requests and purchase orders for contract testing and cell bank testing/production.
- Initiate change requests (CR) for new cell bank production and SOP revisions using TrackWise system.
- Prepare monthly summaries of contract laboratory activities and metrics.
- Perform contract lab performance evaluations and present evaluations during contract lab review forum.
- Assist in the performance of log-based and physical cell bank inventories.
- Request and coordinate cell bank vial shipments to/from offsite biorepository.
- Assist with shipment and samples and reagents to contract labs.
- Support regulatory filings requests
- Support regulatory agency, partner and QP inspections.
- At least 6 years in the biopharmaceutical industry, with at least 2 years in a cGMP laboratory; quality control experience preferred.
- Experience in dealing with contract testing laboratories is highly preferred.
- Managerial/Supervisor experience is a plus.
- Demonstrated ability to perform most tasks with minimal supervision given general instructions on routine work and instructions on new assignments.
- Excellent organizational and project management skills.
- Proficient in MS applications - Excel, PowerPoint, Word.
- Knowledgeable and conversant concerning 21CFR, USP, EP, and ICH regulatory guidelines.
- B.S./B.A. degree with 6 years of experience in biopharmaceutical industry.Thorough knowledge of cGMPs and regulations applicable to the FDA and comparable international regulatory agencies. Excellent written and verbal communication skills.